NCT02470494

Brief Summary

The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

June 8, 2015

Results QC Date

February 10, 2017

Last Update Submit

May 25, 2017

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

  • Change in Hearing Stability Using Unaided Air Conduction Thresholds.

    Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of "No Hearing Change" for the subject was made if the calculated hearing changes of the subject population are 10dB or less.

    Baseline and up to 90-day.

Secondary Outcomes (3)

  • Change in Speech Understanding in Noise.

    Baseline and up to 90-day.

  • Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.

    Baseline and up to 90-day.

  • Change in Subject's Self-Perceived Ability to Communicate.

    Baseline and up to 90-day.

Other Outcomes (1)

  • Adverse Events

    Baseline and up to 90-day.

Study Arms (1)

Sound amplificatoin via EarLens CHD

EXPERIMENTAL

Sound amplification provided via the EarLens CHD for subjects with hearing impairment.

Device: Sound amplification provided via the EarLens CHD

Interventions

Sound amplification provided via the EarLens CHDDEVICE

Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.

Sound amplificatoin via EarLens CHD

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85 years.
  • Mild to severe hearing impairment between 125 to 8000 Hz.
  • Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
  • No significant conductive hearing impairment;
  • No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
  • Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
  • Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
  • Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
  • Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
  • Fluent speaker of American English due to use of American English study materials

You may not qualify if:

  • The Subject must not have known or active medical issues that would preclude having a hearing device, including:
  • an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
  • an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
  • an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
  • an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
  • a history of chronic and recurrent ear infections in the past 24 months;
  • a rapidly progressive or fluctuating hearing impairment;
  • diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
  • Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Hearing and Balance Center

La Jolla, California, 92037, United States

Location

Rodney Perkins Associates

Menlo Park, California, 94025, United States

Location

Camino Ear Nose and Throat Clinic

San Jose, California, 95138, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

CNC Hearing and Balance Center

Marrero, Louisiana, 70072, United States

Location

Carolina Ear and Hearing Clinic

Raleigh, North Carolina, 27609, United States

Location

Pittsburgh Ear Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Ear Medical Group

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

  • Arbogast TL, Moore BCJ, Puria S, Dundas D, Brimacombe J, Edwards B, Carr Levy S. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019 May/Jun;40(3):741-756. doi: 10.1097/AUD.0000000000000661.

    PMID: 30300158DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Suzanne Levy, Director of Clinical Research
Organization
Earlens Corporation
Suzanne.Levy@Earlens.com
650-739-4447

Study Officials

  • Brent Edwards

    EarLens, Corp.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

June 27, 2017

Results First Posted

June 27, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(8)